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Article of the Month: SRP for recurrent Prostate Cancer – Verification of EAU guideline criteria

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Every Month the Editor-in-Chief selects an Article of the Month from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one.

Salvage Radical Prostatectomy for recurrent Prostate Cancer: Verification of EAU guideline criteria

Philipp Mandel*†, Thomas Steuber*†, Sascha Ahyai†, Maximilian Kriegmair‡, Jonas Schiffmann*, Katharina Boehm*, Hans Heinzer*, Uwe Michl*, Thorsten Schlomm*†, Alexander Haese*, Hartwig Huland*, Markus Graefen* and Derya Tilki*†

 

*Martini-Clinic Prostate Cancer Center, †Department of Urology, University Hospital Hamburg-Eppendorf, Hamburg , and ‡Department of Urology, University Hospital Mannheim, Mannheim, Germany

 

Note: Figure 3 should be swapped with Figure 4. The legends for both figures stay the same and the referencing in the text is correct.

Read the full article
OBJECTIVE

To analyse oncological and functional outcomes of salvage radical prostatectomy (SRP) in patients with recurrent prostate cancer and to compare outcomes of patients within and outside the European Association of Urology (EAU) guideline criteria (organ-confined prostate cancer ≤T2b, Gleason score ≤7 and preoperative PSA level <10 ng/mL) for SRP.

PATIENTS AND METHODS

In all, 55 patients who underwent SRP from January 2007 to December 2012 were retrospectively analysed. Kaplan–Meier curves assessed time to biochemical recurrence (BCR), metastasis-free survival (MFS) and cancer-specific survival. Cox regressions addressed factors influencing BCR and MFS. BCR was defined as a PSA level of >0.2 ng/mL and rising, continence as the use of 0–1 safety pad/day, and potency as a five-item version of the International Index of Erectile Function score of ≥18.

RESULTS

The median follow-up was 36 months. After SRP, 42.0% of the patients experienced BCR, 15.9% developed metastasis, and 5.5% died from prostate cancer. Patients fulfilling the EAU guideline criteria were less likely to have positive lymph nodes (LNs) and had significantly better BCR-free survival (5-year BCR-free survival 73.9% vs 11.6%; P = 0.001). In multivariate analysis, low-dose-rate brachytherapy as primary treatment (P = 0.03) and presence of positive LNs at SRP (P = 0.02) were significantly associated with worse BCR-free survival. The presence of positive LNs or Gleason score >7 at SRP were independently associated with metastasis. The urinary continence rate at 1 year after SRP was 74%. Seven patients (12.7%) had complications ≥III (Clavien grade).

CONCLUSION

SRP is a safe procedure providing good cancer control and reasonable urinary continence. Oncological outcomes are significantly better in patients who met the EAU guideline recommendations.

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Editorial: SRP – a few good men

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The current management of recurrent disease after definitive treatment of a localized prostate cancer with radiation therapy (RT) or cryotherapy remains debatable. A substantial portion of patients treated with RT (20–50%) will experience biochemical recurrence. Androgen deprivation therapy has been the mainstay of therapy for this patient population, especially if there was concern about metastatic spread. As the initial experience with salvage radical prostatectomy (SRP) was highly morbid with poor functional outcomes, this did not gain strong acceptance as a recommended treatment method; however, with improved functional outcomes and fewer complications reported in recent series, SRP has once again become a viable alternative in select cases.

The rarity of the procedure makes it difficult to generate large-volume prospective studies on SRP, requiring us to depend on retrospective series. Chade et al. [1] published the largest series of patients undergoing SRP through a multicentre collaborative effort, and were able to identify 404 patients treated between 1985 and 2009; other large series were limited to 50–200 patients. In their systematic review of studies published between 1980 and 2011, Chade et al. [2] reported 5- and 10-year biochemical recurrence-free survival rates of 47–82% and 28–53%, respectively. This broad range of outcomes hints at the variable response of patients to SRP. Identifying the subset of patients who are most likely to benefit from SRP will therefore help tailor therapies for patients who have failed RT, cryotherapy or high-intensity focused ultrasonography.

As described by Mandel et al. [3], there are three sets of guidelines currently addressing patient selection for SRP. The NICE guidelines are the least specific, essentially mentioning SRP as an option for management without specifying specific criteria [4]. The European Association of Urology (EAU) and National Comprehensive Cancer Network guidelines are more specific, and help narrow the patient population to men with clinically localized recurrence (cT1–2), life expectancy of at least 10 years and a preoperative PSA level <10 ng/mL[5, 6]. The EAU guidelines are even more restrictive, limiting selection to men with Gleason ≤7 on prostate biopsy, although they do not specify whether that is before or after RT [5].

In their retrospective analysis of 55 patients treated with SRP between 2007 and 2012, Mandel et al. [3] compare the oncological outcomes of patients treated according to the EAU criteria (n = 32) and those treated without meeting the EAU criteria (n = 23). The 5-year biochemical recurrence-free survival rate was 48.7%, consistent with previous studies, as was the 5-year cancer-specific survival rate of 89%. Importantly, however, after stratification based on EAU criteria, the 5-year biochemical recurrence-free survival rates were drastically different: 73.9% in patients who met the EAU criteria and 11.6% in patients who did not. Patients who did not meet the EAU criteria were more likely to have Gleason score ≥8 (P = 0.08) tumours and pN1 (nodal metastatic) disease at the time of SRP (P = 0.04), which shows the ability of these criteria to select patients with localized disease recurrence. They also established that overall functional outcomes were acceptable after this procedure, with a postoperative urinary continence rate of 74%; none of the patients recovered potency, however, which is not surprising considering the high rate of preoperative erectile dysfunction and the non-nerve-sparing nature of the procedure [3].

In terms of complications, 12.7% of the patients had Clavien ≥ III complications requiring additional intervention. When complications do occur, they can be severe: three of the patients (5.5%) developed rectovesical fistulae and failed conservative management, progressing to fistula repair with omental flap, and two of the patients required permanent urinary diversion. There was no specification, however, regarding which subset of patients experienced these complications. The complication rate was acceptable, and consistent with recent reports of decreased complication rates with SRP [3].

While the study has its limitations as a retrospective review of a relatively small cohort, it is the first to analyse outcomes based on published guidelines criteria, and thereby helps to validate the subset of patients that will benefit from surgical intervention. Based on their findings, appropriately selected patients, those with evidence of truly localized recurrent disease after RT or high-intensity focused ultrasonography, can have significant oncological benefit with acceptable functional outcomes and without significant morbidity. The goal is not to perform SRP indiscriminately, rather to wait for a few good men.

Read the full article
Thenappan Chandrasekar , and Christopher P. Evans
Department of Urology, University of California, Sacramento, CA, USA

 

References

 

1 Chade DC, Shariat SF, Cronin AM et al. Salvage radical prostatectomy for radiation-recurrent prostate cancer: a multi-institutional collaboration. Eur Urol 2011; 60: 205–10

 

2 Chade DC, Eastham J, Graefen M et al. Cancer control and functional outcomes of salvage radical prostatectomy for radiation-recurrent prostate cancer: a systematic review of the literature. Eur Urol 2012; 61: 961–71

 

3 MandelP, Steuber T, Ahyai S et al. Salvage radical prostatectomy for recurrent prostate cancer: verification of European Association of Urology guideline criteria. BJU Int 2015; 117: 55–61

 

4 Prostate cancer: diagnosis and treatment. NICE clinical guideline 175: Hearing before the National Institute for Health and Care Excellence (January 2014).

 

5 Heidenreich A, Bastian PJ, Bellmunt J et al. EAU guidelines on prostate cancer. Part II: treatment of advanced, relapsing, and castration-resistant prostate cancer. Eur Urol 2014; 65: 467–79

 

6 Mohler JL, Kantoff PW, Armstrong AJ et al. Prostate cancer, version 2.2014. JNCCN 2014; 12: 686–718.

 

 

Article of the Week: Recourse to RP and associated short-term outcomes in Italy

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Every Week the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from Mr. Julian Hanske, discussing his editorial. 

If you only have time to read one article this week, it should be this one.

Recourse to radical prostatectomy and associated short-term outcomes in Italy: a country-wide study over the last decade

Giacomo Novara, Vincenzo Ficarra*, Filiberto Zattoni and Ugo Fedeli†

 

Department of Surgery, Oncology, and Gastroenterology, Urology Clinic, University of Padova, Padova, *Department of Experimental and Clinical Medical Sciences, Urologic Clinic, University of Udine, Udine, and †Epidemiological Department, Veneto Region, Italy

 

Read the full article
OBJECTIVE

To estimate time trends in the recourse to radical prostatectomy (RP) and associated short-term outcomes after RP in Italy, as population-based data on RP adoption and outcomes are available mainly from Northern America and Northern Europe.

PATIENTS AND METHODS

All RPs for prostate cancer performed between 2001 and 2010 were extracted from the Italian national archive of hospital discharge records. Age-specific and age-standardised RP rates were computed. The effect of procedural volume on in-hospital mortality, complications, and length of stay (LOS) was estimated by multilevel regression models.

RESULTS

In all, 144 432 RPs were analysed. Country-wide RP rates increased between 2001 and 2004, and thereafter remained stable, with large differences between geographical areas. The mean hospital volume increased in the first study years, without centralisation but due to increasing RP numbers at the population level. The median LOS declined from 10 to 8 days over the study period (mean from 11.7 to 9.2 days). In-hospital mortality declined from 0.16% in 2001 to 0.07% in 2010. In-hospital mortality, LOS, and the prevalence of complications increased with age, and decreased with year of surgery. Compared with very low-volume hospitals, procedures performed in high-volume hospitals were associated with decreased in-hospital mortality, in-hospital complications, and LOS.

CONCLUSIONS

The study adds evidence on rapidly changing trends in RP rates in Italy, on improving in-hospital outcomes, and on their association with procedural volume.

Read more articles of the week

Editorial: How Can We Improve Surgical Outcomes?

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How to improve surgical outcomes for all is a long-standing health policy/services research question. There are generally two perspectives to the debate. One reasonable approach would be to regionalise, or centralise, the performance of a procedure, in this case radical prostatectomy (RP), to ‘specialised’ surgeons or institutions. Data from the USA show that regionalisation of prostate cancer care initially occurred in the late 1990s and even further more recently after the introduction of robotic surgery. The improvement of surgical outcomes after RP in the USA has been partially attributed to such phenomena [1]. Conversely, it may be impossible to centralise a common procedure, such as RP, to a small number of hospitals, concerns that were raised in an review on improving surgical care by Hollenbeck et al. [2]. Alternatively, large state or national quality improvement initiatives, with incremental advances in process-of-care adoption/compliance, may improve the care of prostate cancer for all. This collaborative and inclusive approach is, for example, employed by the Michigan Urological Surgery Improvement Collaborative (MUSIC). However, one has to factor in that this type of approach demands funding, collaboration and patience. Regardless, there is little doubt that both approaches, enforced by health policy or not, are needed in large and diverse countries such as the USA.

In this issue of BJU International, Novara et al. [3] examine the trends in RP utilisation within Italy. The authors have to be commended for their efforts to raise awareness of the need for concerted cancer registries and centralised treatments. They corroborated previous studies on the relationship between hospital volume and perioperative outcomes, such as in-hospital mortality, complications and length of stay [4]. They also found an improvement in perioperative outcomes over time. Although their study design may only allow us to speculate on the reasons for these improvements, they are likely to be the result of many factors, such as improved surgical technique, improved perioperative medical/anaesthetic care and regionalisation of care. For surgical technique, the only significant advance over the past decade was the introduction of robot-assisted RP. Given the late adoption of robotic surgery in Italy and the controversy about its benefits, this is unlikely to be the major driver behind the recorded trends. On perioperative medical/anaesthetic care, the past decade has seen major advances and standardisation of thromboembolic prevention, perioperative care of patients with pre-existing heart conditions and significant comorbidities. Finally, centralisation of care may have played an important role in the decreasing rates of adverse outcomes after RP. Although the authors specify that there was no policy-driven regionalisation of RP care in Italy (relative to the UK, for example), the increase in average hospital volume should translate into better outcomes, as discussed above [4]. Further regionalisation should be expected in Italy with the adoption of robotic surgery, as only a few centres have the means and logistics to support a da Vinci system [5].

Read the full article
Julian Hanske *†, Christian P. Meyer†‡ and Quoc-Dien Trinh†

 

*Department of Urology, Marien Hospital, Ruhr-University Bochum, Herne, Germany, †Division of Urologic Surgery and Center for Surgery and Public Health, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA and ‡Department of Urology, University Medical Centre Hamburg–Eppendorf, Hamburg, Germany

 

References

 

1 Kowalczyk KJ, Levy JM, Caplan CF et al. Temporal national trends of minimally invasive and retropubic radical prostatectomy outcomes from 2003 to 2007: results from the 100% Medicare sample. Eur Urol 2012; 61: 803–9

 

2 Hollenbeck BK, Miller DC, Wei JT, Montie JE. Regionalization of care:centralizing complex surgical procedures. Nat Clin Pract Urol 2005; 2: 461

 

3 Novara G, Ficarra V, Zattoni F, Fedeli U. Recourse to radical prostatectomy and associated short-term outcomes in Italy: a country- wide study over the last decade. BJU Int 2015; 116: 862–7

 

4 Trinh QD, Bjartell A, Freedland SJ et al. A systematic review of the volume–outcome relationship for radical prostatectomy. Eur Urol 2013; 64: 786–98

 

5 Makarov DV, Yu JB, Desai RA, Penson DF, Gross CP. The association between diffusion of the surgical robot and radical prostatectomy rates. Med Care 2011; 49: 333–9

 

Video: How Can We Improve Surgical Outcomes?

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Recourse to radical prostatectomy and associated short-term outcomes in Italy: a country-wide study over the last decade

Giacomo Novara, Vincenzo Ficarra*, Filiberto Zattoni and Ugo Fedeli†

 

Department of Surgery, Oncology, and Gastroenterology, Urology Clinic, University of Padova, Padova, *Department of Experimental and Clinical Medical Sciences, Urologic Clinic, University of Udine, Udine, and †Epidemiological Department, Veneto Region, Italy

 

Read the full article
OBJECTIVE

To estimate time trends in the recourse to radical prostatectomy (RP) and associated short-term outcomes after RP in Italy, as population-based data on RP adoption and outcomes are available mainly from Northern America and Northern Europe.

PATIENTS AND METHODS

All RPs for prostate cancer performed between 2001 and 2010 were extracted from the Italian national archive of hospital discharge records. Age-specific and age-standardised RP rates were computed. The effect of procedural volume on in-hospital mortality, complications, and length of stay (LOS) was estimated by multilevel regression models.

RESULTS

In all, 144 432 RPs were analysed. Country-wide RP rates increased between 2001 and 2004, and thereafter remained stable, with large differences between geographical areas. The mean hospital volume increased in the first study years, without centralisation but due to increasing RP numbers at the population level. The median LOS declined from 10 to 8 days over the study period (mean from 11.7 to 9.2 days). In-hospital mortality declined from 0.16% in 2001 to 0.07% in 2010. In-hospital mortality, LOS, and the prevalence of complications increased with age, and decreased with year of surgery. Compared with very low-volume hospitals, procedures performed in high-volume hospitals were associated with decreased in-hospital mortality, in-hospital complications, and LOS.

CONCLUSIONS

The study adds evidence on rapidly changing trends in RP rates in Italy, on improving in-hospital outcomes, and on their association with procedural volume.

Read more articles of the week

Should radiotherapy be a routine added-treatment for patients with N0,N+ non-metastatic prostate cancer on hormonal therapy?

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ISTOnce again we are approaching the end of another productive year in urological research. The final meeting of the year of the International Urology Journal Club #urojc was held from Monday December 7th to Wednesday December 8th AEDT. This month’s topic was a recent paper published in @JAMAOnc by the well-known STAMPEDE group.

In this new analysis of the STAMPEDE trial, the subject was the control arm. The trial’s definitive primary outcome was to evaluate the overall survival when adding radiotherapy (RT) to the cohort of N0 and N+ M0 high risk prostate cancer patients receiving hormonal therapy. The intermediate primary outcome was the failure-free survival (FFS), which was defined as biochemical failure, progression (locally, lymph nodes, or distant metastases) or death from prostate cancer.

The first comments of the discussion were about the satisfaction of a new study evaluating the beneficial effect of RT in addition to ADT in N+M0 disease. For the N0M0 Sub-cohort, 2 year survival was 97% (95% CI, 93%-99%), and 84% (95% CI, 74%-91%) were still alive after 5 years. On the other hand, for the N+M0 sub-cohort, 2 year survival was 93% (95% CI, 88%-96%), and 71% (95% CI, 56%-82%) were still alive after 5 years.

FFS was better with received RT in both groups: In the N0M0 sub-cohort the adjusted HR was 0.25 (95% CI, 0.13-0.49) with 2 year FFS of 96% (95% CI, 90%-98%) in patients receiving RT compared with 73% (95% CI, 57%-84%) in those not reporting RT (Figure). In the N+M0 the results were similar, with an adjusted HR of 0.35 (95% CI, 0.19-0.65), and a 2-year FFS of 89% (95% CI, 77%-94%) and 64% (95% CI, 51%-75%), respectively.

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Since this approach to high-risk N0,+ M0 disease is not a standard of treatment, there were some concerns about urologist opinions, and mainly, about the side-effects of pelvic radiation.

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This trial showed the adverse effects associated with RT, split by N0M0 and N+M0. The majority (78%) of N+M0 received conventionally fractionated RT to prostate and pelvis, and of the N0M0, 46% received it only to prostate and 42% to prostate and pelvis. The reported adverse effects were similar for patients with and without nodal involvement, with no grade 4 or 5 adverse effects reported.

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Another question during the discussion was about the control group and the different baseline characteristics of the patients if comparing to other countries (mainly previous surgery).

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Most urologists conclude that this information contributes to the growing evidence of the different modalities of treatment that should be offered to patients with prostate cancer. Every urologist focused on the importance of determining the risk and stage of the patient to give an appropriate treatment. They also mentioned how these results correlate with other treatment outcomes.

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The previous published trials about the subject conclude that this combination reduces the risk of prostate cancer death; however, the population of those studies varies. Most patients were low-risk N0M0 prostate cancer and none were N+M0.

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Other thoughts were shared, such as the usefulness of ADT for high-risk M0 prostate cancer, the prostate cancer stage and its relation to treatment response, and the needed collaboration of other specialties for study trials.

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We still have to remember that the study has some limitations, though: The study population is drawn from a control arm of a clinical trial. There is no randomization of patients, and those planned for radiotherapy were the ones considered fit for it, so there might be an overestimated benefit biased by a better prognosis.

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Indeed this is not the last of the STAMPEDE trials. One of the authors, @Prof_Nick_James mentioned redoing analysis of all the arms to evaluate more parameters about the outcomes of the different treatments.

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This topic raises many questions about the treatment approaches to high-risk prostate cancer. As the authors expressed “There is a need for randomized clinical trials within the N+M0 population to address questions prospectively”. So far the results shown seem to be of benefit, and support the routine use of radiotherapy in patients with N+M0 prostate cancer. But as usual, we always need more proof.

This is the last meeting of 2015, so I have to finish this summary with a “Merry Christmas and Happy New Year 2016” to all the Urological twitter family!

 

Irela Soto Troya is a urologist born and trained in the Republic of Panama, and is a Fellow at Severance Hospital/Yonsei Medical Health System, Seoul, South Korea.
Twitter @irela_soto

 

 

Article of the Week: Comparison of systematic transrectal biopsy to transperineal MRI/(US)-fusion biopsy for the diagnosis of prostate cancer

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Every Week the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from Dr. Angelika Borkowetz, discussing her paper. 

If you only have time to read one article this week, it should be this one.

Comparison of systematic transrectal biopsy to transperineal MRI/ultrasound-fusion biopsy for the diagnosis of prostate cancer

Angelika Borkowetz, Ivan Platzek*, Marieta Toma†, Michael Laniado*, Gustavo Baretton†, Michael Froehner, Rainer Koch‡, Manfred Wirth and Stefan Zastrow

 

Department of Urology, *Department of Radiology and Interventional Radiology, †Department of Pathology, and ‡Institution of Medical Statistics and Epidemiology, Technische Universitat, Dresden, Germany

 

Read the full article
OBJECTIVES

To compare targeted, transperineal magnetic resonance imaging (MRI)/ultrasound (US)-fusion biopsy to systematic transrectal biopsy in patients with previous negative or first prostate biopsy and to evaluate the gain in diagnostic information with systematic biopsies in addition to targeted MRI/US-fusion biopsies.

PATIENTS AND METHODS

In all, 263 consecutive patients with suspicion of prostate cancer were investigated. All patients were evaluated by 3-T multiparametric MRI (mpMRI) applying the European Society of Urogenital Radiology criteria. All patients underwent MRI/US-fusion biopsy transperineally (mean nine cores) and additionally a systematic transrectal biopsy (mean 12 cores).

RESULTS

In all, 195 patients underwent repeat biopsy and 68 patients underwent first biopsy. The median age was 66 years, median PSA level was 8.3 ng/mL and median prostate volume was 50 mL. Overall, the prostate cancer detection rate was 52% (137/263). MRI/US-fusion biopsy detected significantly more cancer than systematic prostate biopsy (44% [116/263] vs 35% [91/263]; P = 0.002). In repeat biopsy, the detection rate was 44% (85/195) in targeted and 32% (62/195) in systematic biopsy (P = 0.002). In first biopsy, the detection rate was 46% (31/68) in targeted and 43% (29/68) in systematic biopsy (P = 0.527). In all, 80% (110/137) of biopsy confirmed prostate cancers were clinically significant. For the upgrading of Gleason score, 44% (32/72) more clinically significant prostate cancer was detected by using additional targeted biopsy than by systematic biopsy alone. Conversely, 12% (10/94) more clinically significant cancer was found by systematic biopsy additionally to targeted biopsy.

CONCLUSIONS

MRI/US-fusion biopsy was associated with a higher detection rate of clinically significant prostate cancer while taking fewer cores, especially in patients with prior negative biopsy. Due to a high portion of additional tumours with Gleason score ≥7 detected in addition to targeted biopsy, systematic biopsy should still be performed additionally to targeted biopsy.

Read more articles of the week

Editorial: Are men who are biopsied without prior prostate magnetic resonance imaging getting substandard care?

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The article by Borkowetz et al. [1], published in this issue, by a multi-disciplinary group from Dresden who have been offering MRI to their patients since 2012, would suggest so. In their hands, an image-guided biopsy resulted in 29 patients with Gleason scores of 7 or 8 being identified, who had been overlooked by an optimised 12-core systematic biopsy taken at the same sitting. Dedicating a minimum of two cores to a ‘target’ conferred an increase in detection of clinically significant prostate cancer, as defined by Gleason pattern ≥4, of 43% compared with systematic biopsy alone.

There is reason to think that, if anything, this might be an underestimate of the utility of sampling a target of high propensity for clinically significant prostate cancer vs a strategy that tries to spread the needle around the posterior limits of the gland. The reason for this is that the operator was aware of the location of the target during the systematic biopsy, as these were done after the targeted biopsy. The resulting incorporation bias should not trouble us too much, as its effect will be to make systematic biopsy ‘better’ and therefore diminish any difference between the two strategies. The fact that the patients had their systematic biopsy under anaesthesia and were in lithotomy (non-standard conditions) might add further to both bias and direction.

This study [1], like many before, incorporates a mixed population that comprises men who were biopsy-naïve (around one-quarter of the population) and those men who had undergone at least one previous biopsy. Again, this probably does not matter for our purposes, as the two groups were identical for overall cancer detection (52%) and very similar in terms of the proportion of patients with Gleason pattern ≥4 (80% for biopsy-naïve men vs 72% for those who had undergone a previous biopsy). The two groups had a similar number of lesions, around two lesions/subject were declared. The two groups did differ in PSA level; men undergoing repeat biopsy had a median PSA level twice that of men having a biopsy for the first time (12.2 vs 6.1 μg/L).

These results appear to be consistent with those summarised in a recent systematic review of studies that compared a targeted sampling strategy with another [2], but they do differ substantially from a recent study of >1000 biopsy-naïve men who were randomised to MRI vs a standard systematic TRUS biopsy approach [3]. In this large randomised controlled trial from Rome, the overall detection rate in MRI-positive individuals who underwent targeted sampling was 93% (410/440) vs the 52% (137/263) achieved in this study [1].

Both studies show higher detection rates compared with a standard systematic approach, and both show that targeting increases the proportion of men with clinically significant disease. However, exploring the differences between the studies might provide us with insight on how best to refine this new intervention. At present, the detection rate of clinically significant cancer (the generally agreed desired outcome of a biopsy when clinically significant disease is indeed present) is contingent on several variables [4]. They comprise the following: the population sampled; the target condition employed (definition of clinical significance); quality of the imaging; quality of the reporting; the threshold used for declaring a ‘lesion’ a target; the accuracy of the needle placement; the number of cores deployed to the target; and the efficiency of tissue capture. All these differed between the two studies, either explicitly or implicitly.

However, it is likely that the one with the greatest influence on the outcome is the level of certainty attributed to the lesion by the radiologist. There are several scales currently in use and this study used the Prostate Imaging Reporting and Data System (PI-RADS), which comprises an ordinal scale, range 1–5, derived from conditions being either met or unmet [5]. Ideally, a risk stratification system should influence clinical practice. A PI-RADS score of 1–2 should result in avoidance of a biopsy, because of the low probability of finding clinically significant disease. A PI-RADS score of 4–5 should result in a targeted biopsy, because of the high probability of underlying clinically significant disease. A PI-RADS 3 score should prompt a repeat assessment after a given interval, reflecting the indeterminate nature of the prediction.

In the study by Borkowetz et al. [1], PI-RADS scores of 2 and 3 were both associated with a 10% rate of Gleason pattern ≥4, suggesting poor discriminant ability between the two. On the other hand, PI-RADS scores of 4 and 5 were associated with a 24% and 60% detection rate, respectively, of Gleason pattern ≥4. From this we can say that lesions with PI-RADS scores of 4–5 should be targeted, are positively associated with risk, and will confer a high targeting yield. I think we can also say that more work is needed in relation to the inputs that generate PI-RADS 2–3 scores. This, fortunately, is in hand, as a new version of PI-RADS is soon to replace the one used in this article. Hopefully, it will improve the discriminant quality at the lower limits of PI-RADS and, as a result, should allow us to avoid incorporating a PI-RADS score of 2 into our targeting schedule.

Despite issues with the finessing of PI-RADS and other scoring systems, a task that will never be fully complete, this study adds to the burden of proof. What we can say, quite emphatically (based on this study, the systematic review and other studies published since), is that if patients want to maximise the chances of finding clinically significant prostate cancer, if it is indeed present, they should insist on an MRI before biopsy, so that targeting can be incorporated into the sampling strategy. To do otherwise would, according to this study, just about halve the chances of detecting clinically significant prostate cancer, if it were present.

Read the full article
Mark Emberton
UCL Division of Surgery and Interventional Science, UCL, London, UK

 

References

 

1 Borkowetz A, Platzek I, Toma M et al. Comparison of systematic transrectal biopsy to transperineal MRI/ultrasound-fusion biopsy for the diagnosis of prostate cancer. BJU Int 2015; 116: 873–9

 

2 Moore CM, Robertson NL, Arsanious N et al. Image-guided prostate biopsy using magnetic resonance imaging-derived targets: a systematic review. Eur Urol 2013; 63: 125–40.

 

3 Panebianco V, Barchetti F, Sciarra A et al. Multiparametric magnetic resonance imaging vs standard care in men being evaluated for prostate cancer: a randomized study. Urol Oncol 2015; 33: 17.e1–7.

 

4 Moore CM, Kasivisvanathan V, Eggener S et al. Standards of reporting for MRI-targeted biopsy studies (START) of the prostate: recommendations from an international working group. Eur Urol 2013; 64: 544–52.

 

5 VacheT, Bratan F, Mege-Lechevallier F, Roche S, Rabilloud M, Rouviere O. Characterization of prostate lesions as benign or malignant at multiparametric MR imaging: comparison of three scoring systems in patients treated with radical prostatectomy. Radiology 2014; 272: 446–55.

 

 

Video: Comparison of systematic transrectal biopsy to transperineal MRI/(US)-fusion biopsy for the diagnosis of prostate cancer

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Comparison of systematic transrectal biopsy to transperineal MRI/ultrasound-fusion biopsy for the diagnosis of prostate cancer

Angelika Borkowetz, Ivan Platzek*, Marieta Toma†, Michael Laniado*, Gustavo Baretton†, Michael Froehner, Rainer Koch‡, Manfred Wirth and Stefan Zastrow

 

Department of Urology, *Department of Radiology and Interventional Radiology, †Department of Pathology, and ‡Institution of Medical Statistics and Epidemiology, Technische Universitat, Dresden, Germany

 

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OBJECTIVES

To compare targeted, transperineal magnetic resonance imaging (MRI)/ultrasound (US)-fusion biopsy to systematic transrectal biopsy in patients with previous negative or first prostate biopsy and to evaluate the gain in diagnostic information with systematic biopsies in addition to targeted MRI/US-fusion biopsies.

PATIENTS AND METHODS

In all, 263 consecutive patients with suspicion of prostate cancer were investigated. All patients were evaluated by 3-T multiparametric MRI (mpMRI) applying the European Society of Urogenital Radiology criteria. All patients underwent MRI/US-fusion biopsy transperineally (mean nine cores) and additionally a systematic transrectal biopsy (mean 12 cores).

RESULTS

In all, 195 patients underwent repeat biopsy and 68 patients underwent first biopsy. The median age was 66 years, median PSA level was 8.3 ng/mL and median prostate volume was 50 mL. Overall, the prostate cancer detection rate was 52% (137/263). MRI/US-fusion biopsy detected significantly more cancer than systematic prostate biopsy (44% [116/263] vs 35% [91/263]; P = 0.002). In repeat biopsy, the detection rate was 44% (85/195) in targeted and 32% (62/195) in systematic biopsy (P = 0.002). In first biopsy, the detection rate was 46% (31/68) in targeted and 43% (29/68) in systematic biopsy (P = 0.527). In all, 80% (110/137) of biopsy confirmed prostate cancers were clinically significant. For the upgrading of Gleason score, 44% (32/72) more clinically significant prostate cancer was detected by using additional targeted biopsy than by systematic biopsy alone. Conversely, 12% (10/94) more clinically significant cancer was found by systematic biopsy additionally to targeted biopsy.

CONCLUSIONS

MRI/US-fusion biopsy was associated with a higher detection rate of clinically significant prostate cancer while taking fewer cores, especially in patients with prior negative biopsy. Due to a high portion of additional tumours with Gleason score ≥7 detected in addition to targeted biopsy, systematic biopsy should still be performed additionally to targeted biopsy.

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Article of the Week: Predicting pathological outcomes in patients undergoing RARP for high-risk prostate cancer

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Every Week the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from Dr. Firas Abdollah, discussing his paper. 

If you only have time to read one article this week, it should be this one.

Predicting Pathologic Outcomes in Patients Undergoing Robot-Assisted Radical Prostatectomy for High Risk Prostate Cancer:  A Preoperative Nomogram

Firas Abdollah, Dane E. Klett, Akshay Sood, Jesse D. Sammon, Daniel Pucheril, Deepansh Dalela, Mireya Diaz, James O. Peabody, Quoc-Dien Trinh* and Mani Menon

 

Vattikuti Urology Institute, Center for Outcomes Research Analytics and Evaluation, Henry Ford Health System, Detroit, MI, and *Division of Urologic Surgery/Center for Surgery and Public Health, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

 

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OBJECTIVE

To identify which high-risk patients with prostate cancer may harbour favourable pathological outcomes at radical prostatectomy (RP).

PATIENTS AND METHODS

We evaluated 810 patients with high-risk prostate cancer, defined as having one or more of the following: PSA level of >20 ng/mL, Gleason score ≥8, clinical stage ≥T2c. Patients underwent robot-assisted RP (RARP) with pelvic lymph node dissection, between 2003 and 2012, in one centre. Only 1.6% (13/810) of patients received any adjuvant treatment. Favourable pathological outcome was defined as specimen-confined disease (SCD; pT2–T3a, node negative, and negative surgical margins) at RARP-specimen. Logistic regression models were used to test the relationship among all available predicators and harbouring SCD. A logistic regression coefficient-based nomogram was constructed and internally validated using 200 bootstrap resamples. Kaplan–Meier method estimated biochemical recurrence (BCR)-free and cancer-specific mortality (CSM)-free survival rates, after stratification according to pathological disease status.

RESULTS

Overall, 55.2% patients harboured SCD at RARP. At multivariable analysis, PSA level, clinical stage, primary/secondary Gleason scores, and maximum percentage tumour quartiles were all independent predictors of SCD (all P < 0.04). A nomogram based on these variables showed 76% discrimination accuracy in predicting SCD, and very favourable calibration characteristics. Patients with SCD had significantly higher 8-year BCR- (72.7% vs 31.7%, P < 0.001) and CSM-free survival rates (100% vs 86.9%, P < 0.001) than patients with non-SCD.

CONCLUSIONS

We developed a novel nomogram predicting SCD at RARP. Patients with SCD achieved favourable long-term BCR- and CSM-free survival rates after RARP. The nomogram may be used to support clinical decision-making, and aid in selection of patients with high-risk prostate cancer most likely to benefit from RARP.

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